AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Summary
The FDA issued a Class II for AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 by BioMimetic Therapeutics, LLC. Reason: The kit contains the wrong vial tray in the package..
Details
Source
Device Recall
External ID
Z-2335-2021
Action Date
2021-09-01
Status
Terminated
Category
device
Product Description
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Lot/Code Info: Model Number K30003010, Lot 1706343
Quantity Affected: 499 units
Reason for Recall
The kit contains the wrong vial tray in the package.
Distribution
US Nationwide distribution in the states of AK, CA, CO, FL, GA, IA, ID, IL, IN, MA, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-23
Company
Franklin, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioMimetic Therapeutics, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioMimetic Therapeutics, LLC have FDA actions?
This is the only FDA action we have on record for BioMimetic Therapeutics, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2335-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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